Posted in

Director – Human Factors

Director – Human Factors

CompanyAstraZeneca
LocationBoston, MA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelExpert or higher

Requirements

  • Degree in human factors engineering, mechanical engineering, bioengineering or related field is required
  • 10+ years’ experience in combination product or medical device development
  • At least 7 years focused on human factors engineering (HFE)
  • Strong depth of knowledge in Human Factors engineering including a working knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management
  • Strong communication skills with an ability to influence internal partners as well as external industry and health authorities
  • Ability to lead a global team, create a positive work environment and effectively develop staff

Responsibilities

  • Lead Human Factors efforts for combination product and new technology development including ethnography, requirements definition research, formative studies, instruction and training development, risk analysis and summative studies
  • Write and review HF sections for health authority submissions
  • Interact with health authorities during face to face meetings and in written responses
  • Engage AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and standard processes
  • Manage HF engineers and mentor the group professionally
  • Be a voice of user centricity across all product types in AstraZeneca
  • Be engaged with and influence Human Factors standard processes externally across industry and with regulators
  • Improving internal Human Factors processes to ensure consistency, compliance and efficiency

Preferred Qualifications

    No preferred qualifications provided.